GORE ACUSEAL Vascular GraftRecalls & reported problems across all models

We found 6 models of GORE ACUSEAL Vascular Graft by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jan 22, 2020 and Aug 11, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GORE ACUSEAL Vascular Graft recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 26, 2025Class IIOpen, Classified

   Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.

   Z-0036-2026 · Root cause: Unknown/Undetermined by firm · names 5 of these models · Recall details · FDA record ↗

Most reported GORE ACUSEAL Vascular Graft problems

GORE ACUSEAL Vascular Graft models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE ACUSEAL Vascular Graft ECH060040A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 recall2 reports
• GORE ACUSEAL Vascular Graft ECH460045A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 recall1 report
• GORE ACUSEAL Vascular Graft ECH060010A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 recall0 reports
• GORE ACUSEAL Vascular Graft ECH060020A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 recall0 reports
• GORE ACUSEAL Vascular Graft ECH060050A

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 recall0 reports
• GORE ACUSEAL Vascular Graft ECH470045A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  3 reports

Recent GORE ACUSEAL Vascular Graft adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A DIALYSIS PATIENT WAS IMPLANTED WITH A GORE® ACUSEAL VASCULAR GRAFT (ACUSEAL VG) FOR DIALYSIS ACCESS IN THE RIGHT FOREARM. ON (B)(6) 2025, THE PATIENT PRESENTED WITH A LARGE HEMATOMA AT THE IMPLANT LOCATION. THE EDEMA INVOLVING THE EPIDERMIS WAS DRAINED. AS REPORTED, THE ACUSEAL VG HAD NOT BEEN CANNULATED. THE PHYSICIAN STATED THE PATIENT APPEARS TO HAVE DEVELOPED AN ALLERGIC REACTION. THE PATIENT DOES NOT HAVE HIT TYPE 2 OR ANY KNOWN ALLERGIES. AN UPDATE WAS PROVIDED ON (B)(6) 2025. IT WAS REPORTED THE CONDITION OF THE PATIENT'S ARM HAS GREATLY IMPROVED, WITH SOME REMAINING EDEMA. THERE ARE NO PLANS FOR ADDITIONAL INTERVENTION OR GRAFT EXPLANT.

  Patient problems: Hematoma

  MAUDE report 22772139 ↗
• InjuryMar 12, 2025Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: A PATIENT PRESENTED FOR AN ARTERIOVENOUS (A-V) ACCESS REVISION IN THE LEFT UPPER ARM. AS REPORTED, AN A-V GRAFT LOOP (GORE® ACUSEAL VASCULAR GRAFT) WAS IMPLANTED ON (B)(6) 2025. NOW THE LOOP GRAFT HAD CLOTTED AND REQUIRED AN OPEN THROMBECTOMY. FISTULAGRAM ON BOTH ARTERIAL AND VENOUS ANASTOMOSIS REVEALED SIGNIFICANT STENOSIS TO THE VENOUS OUTFLOW THAT REQUIRED STENTING. ON (B)(6) 2025, AN 8FR X 10CM BRITE TIP SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) TO THE INTENDED TREATMENT SITE. THE VIABAHN DEVICE WAS PLACED AND DEPLOYED FINE. AS THE DELIVERY CATHETER WAS WITHDRAWN, THE DISTAL TIP CAUGHT ON THE EDGE OF THE SHEATH. IT WAS REPORTED THE DISTAL TIP CAME OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DISTAL TIP ALONG WITH THE SHEATH REMOVAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21589085 ↗
• InjuryApr 12, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO GORE THAT THE GORE® ACUSEAL VASCULAR GRAFT DELAMINATED POST PROCEDURE. REPORTEDLY, DR. (B)(6) STATED THAT THE ACUSEAL DELAMINATED AND HER COULD VISUALIZE IT ON ULTRASOUND. IT WAS REPORTED THAT THE PHYSICIAN DETERMINED THE GRAFT AND ACCESS WERE COMPROMISED, SO THE PATIENT WAS TAKEN TO SURGERY AND REVISED THE GRAFT WITH ANOTHER PIECE OF ACUSEAL. REPORTEDLY THE PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087366 ↗
• InjuryFeb 8, 2022Peeled/Delaminated; Peeled/Delaminated

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE, A PATIENT UNDERWENT REVISION OF AN AV FISTULA INVOLVING A GORE® ACUSEAL VASCULAR GRAFT THAT HAD BEEN IMPLANTED IN (B)(6) 2019. IT WAS REPORTED THAT THERE WAS POSSIBLE DELAMINATION. MORE INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13479724 ↗
• InjuryFeb 3, 2021Peeled/Delaminated; Peeled/Delaminated

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE IN (B)(6) 2020, AN INTERPOSITION BASILIC VEIN GORE® ACUSEAL VASCULAR GRAFT WAS IMPLANTED FOR DIALYSIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE SURGEON PERFORMED A VENOGRAM AND OBSERVED AN IRREGULARITY IN THE GRAFT. ON (B)(6) 2021, THE PHYSICIAN ADVANCED A BARD COVERA 7MM X 40MM TO TRY TO OVERCOME THE IRREGULARITY BUT DURING THE PROCEDURE, THE IRREGULARITY MOVED FURTHER DOWN TO MAKE ANOTHER IRREGULARITY IN THE GORE® ACUSEAL VASCULAR GRAFT. THE PHYSICIAN THEN OPERATED TO ELEVATE THE GORE® ACUSEAL VASCULAR GRAFT AND NOTED THAT THE INNER LAYER HAD SEPARATED FROM THE OUTER LAYER FOR APPROXIMATELY TWO INCHES IN LENGTH. THE PHYSICIAN PROCEEDED TO EXCISE THE DELAMINATED PORTION AND IMPLANT A NEW GORE® ACUSEAL VASCULAR GRAFT TO REPLACE THE EXCISED SECTION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11275062 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT RECEIVED A FISTULA FOR AV ACCESS AT THE UNIVERSITY HOSPITAL OF (B)(6) AND IS SENT HOME TO (B)(6) FOR DIALYSIS AT FRESENIUS KIDNEY CARE. AFTER APPROXIMATELY 2 WEEKS OF DIALYSIS WITH THE FISTULA, THE PATIENT RETURNS TO UNIVERSITY HOSPITAL OF (B)(6), AS THE FISTULA HAS BECOME NON-FUNCTIONAL (UNABLE TO BE USED FOR DIALYSIS). THE FISTULA IS ABANDONED AND THE SURGEON WHO CREATED THE FISTULA, IMPLANTS A GORE® ACUSEAL VASCULAR GRAFT ON (B)(6) 2020 IN THE UPPER ARM. THE PATIENT RETURNS TO HAZARD, KENTUCKY FOR DIALYSIS. PATIENT PRESENTED AT FRESENIUS KIDNEY CARE ((B)(6)) FOR DIALYSIS (B)(6) 2020 (2 DAYS POST IMPLANT). TWO 17 GAUGE DIALYSIS NEEDLES ARE USED TO ACCESS INFLOW AND OUTFLOW OF THE ACUSEAL GRAFT AND THE DIALYSIS MACHINE IS ADJUSTED TO 100ML PER MINUTE FOR THE INITIAL TIME PERIOD ON DIALYSIS. DURING THE DIALYSIS SESSION THE PATIENT COMPLAINED ABOUT ARM PAIN AND SWELLING/HEMATOMA WAS OBSERVED. THE PATIENT WAS SENT TO (B)(6) MEDICAL CENTER ER WITH THE TWO DIALYSIS NEEDLES STILL IN THE ARM. FASCIOTOMY IS PERFORMED TO CONTROL BLEEDING AND TO TREAT COMPARTMENT SYNDROME. THE ER SURGEON REPORTED THERE WERE NO VISIBLE PROBLEMS ASSOCIATED WITH

  Patient problems: Blood Loss; Fistula

  MAUDE report 9618623 ↗

Other W. L. Gore & Associates, Inc. products

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
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• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports